Evidence map›Paper›PMID 28950351›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017

Phase II randomized trial of carboplatin, paclitaxel, bevacizumab with or without cixutumumab (IMC-A12) in patients with advanced non-squamous, non-small-cell lung cancer: a trial of the ECOG-ACRIN Cancer Research Group (E3508).

A Argiris, J W Lee, J Stevenson, M G Sulecki, V Hugec, N W Choong, J N Saltzman, W Song, R M Hansen, T L Evans and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00955305 (A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab With or Without IMC-A12 in Patients With Advanced Non-squamous, Non-small Cell Lung Cancer), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00955305 phase2terminatednot on this map

A Phase II Randomized Trial of Paclitaxel, Carboplatin, Bevacizumab With or Without IMC-A12 in Patients With Advanced Non-squamous, Non-small Cell Lung Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2010 to 2016Enrolled175ConditionsLarge Cell Lung Carcinoma, Lung Adenocarcinoma, Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung CancerArmsBevacizumab, Carboplatin, Cixutumumab, Paclitaxel
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. [Anti-angiogenesis in Lung Cancer: Current Situation, Progress and Confusion].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2022
    Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 3 countries.

A ArgirisMedical Oncology, Hygeia Hospital, Athens, Greece.
J W LeeDana-Farber Cancer Institute, ECOG-ACRIN Biostatistics Center, Boston.
J StevensonMedical Oncology, Cleveland Clinic Foundation, Cleveland.
M G SuleckiMedical Oncology, University of Pittsburgh Cancer Institute, Pittsburgh.
V HugecMedical Oncology, Minnesota Oncology, Minneapolis, Lake Elmo.
N W ChoongGenentech, Inc., South San Francisco.
J N SaltzmanMedical Oncology, University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland.
W SongPottstown Memor Reg Cancer Ctr, Pottstown.
R M HansenMedical Oncology, Oconomowoc Memorial Hospital, Oconomowoc.
T L EvansMedical Oncology, University of Pennsylvania, Philadelphia.
S S RamalingamThe Winship Cancer Institute of Emory University, Atlanta.
J H SchillerMedical Oncology, The University of Texas Southwestern Medical Center, Dallas, USA.
Cleveland Clinic · USECOG-ACRIN Cancer Research Group · USEmory University · USMinnesota Oncology · USProHealth Oconomowoc Memorial Hospital · USThe University of Texas Southwestern Medical Center · USThomas Jefferson University · USUniversity Hospitals Seidman Cancer Center · USUniversity of Pennsylvania · USUPMC Hillman Cancer Center · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820
6 · The paper itself

Abstract

backgroundCixutumumab is a fully human IgG1 monoclonal antibody to the insulin-like growth factor type I receptor that can potentially reverse resistance and enhance the efficacy of chemotherapy.

methodsBevacizumab-eligible patients with stage IV or recurrent non-squamous, non-small-cell lung cancer and good performance status were randomized to receive standard doses of paclitaxel, carboplatin, and bevacizumab to a maximum of six cycles followed by bevacizumab maintenance (CPB) until progression (arm A) or CPB plus cixutumumab 6 mg/kg i.v. weekly (arm B).

resultsOf 175 patients randomized, 153 were eligible and treated (78 in arm A; 75 in arm B). The median progression-free survival was 5.8 months (95% CI 5.4-7.1) in arm A versus 7 months (95% CI 5.7-7.6) in arm B (P = 0.33); hazard ratio 0.92 (95% CI 0.65-1.31). Objective response was 46.2% versus 58.7% in arm A versus arm B (P = 0.15). The median overall survival was 16.2 months in arm A versus 16.1 months in arm B (P = 0.95). Grade 3/4 neutropenia and febrile neutropenia, thrombocytopenia, fatigue, and hyperglycemia were increased with cixutumumab.

conclusionsThe addition of cixutumumab to CPB increased toxicity without improving efficacy and is not recommended for further development in non-small-cell lung cancer. Both treatment groups had longer OS than historical controls which may be attributed to several factors, and emphasizes the value of a comparator arm in phase II trials. CLINICALTRIALS.GOV IDENTIFIER: NCT00955305.

Indexed as

AdenocarcinomaAdenocarcinoma of LungAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungDisease-Free SurvivalDrug Administration ScheduleFemaleHumansLung NeoplasmsMalePaclitaxelSurvival RateAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBevacizumabCarboplatincixutumumabPaclitaxelbevacizumabcarboplatincixutumumabnon-small-cell lung cancerpaclitaxel

Identifiers

PMID28950351
PMCPMC5834066
OpenAlexW2755391516

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.